BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    MDR report key: 21799257 · Received April 8, 2025

    Report

    Report Number
    3006948883-2025-00058
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    March 11, 2025
    Report Date
    April 18, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1.DHR/BHR REVIEW (LOT#4052011): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAR 2024, AND PACKAGED AT R240 PACKAGE LINE IN MAR 2024. WORK ORDER QUANTITY WAS (B)(4) EA. 2) REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3)REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. FUNCTION TEST (45PSI LEAKAGE TEST) IS PERFORMED ON RETAINED SAMPLE OF THE COMPLAINT BATCH, THE RESULT IS QUALIFIED, NO LEAKAGE IS FOUND. 4. THIS DEVICE (SKU 383083) HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. SINCE THE PRODUCT IS NOT SUITABLE FOR HIGH-PRESSURE INJECTION, THE ROOT CAUSE OF THE COMPLAINT MAY BE RELATED TO THE INCORRECT USE OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC LEAKED WITH POWER INJECTOR.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721496 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown